Lupin’s Nagpur plant passes FDA inspection

Pharma major Lupin said its Nagpur plant has passed a Pre-Approval Inspection by the US Food and Drug Administration without incident.

The inspection, carried out in September, was related to the manufacture of Phenytoin Sodium Extended Release capsules to be sold in the US market.

Lupin’s Nagpur facility is the company’s latest site and manufactures Oral Solid Dosage products. The site also houses Lupin’s state of the art injectable manufacturing facility.

“The receipt of the Establishment Inspection Report for our Nagpur facility is a positive development as we continue our journey on meeting and exceeding global quality standards at all of our facilities,” said Lupin MD Nilesh Gupta.

Lupin gets US FDA nod for pneumonia drug 2018-09-12 Pharmaceuticals manufacturer Lupin said it has received US authorities' approval to sell pneumonia medicine Atovaquone suspension. The drug had sales…